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FDA: Pradaxa vs. Warfarin Study Results Announced

The FDA announced the results of a new study on Medicare patients comparing Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim Pharmaceuticals) vs. warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.

FDA Updates on Bleeding Risk of Pradaxa

The FDA's recommendations regarding Pradaxa remain unchanged following the November 2012 Mini-Sentinel evaluations. Findings showed that bleeding rates associated with Pradaxa use during the period did not appear to be higher than those associated with warfarin.

Pradaxa Label Updated with New Contraindication

Boehringer Ingelheim announced that the prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
Safety Alerts and Recalls, Uncategorized

Single Lot of Pradaxa 75mg Recalled

Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.